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Clinical trialNCT06705478SuspendedPhase 2Interventional

Pramipexole Versus Escitalopram to Treat Major Depressive Disorder (MDD) and Comorbid MDD With Mild Neurocognitive Disorder (MND) in Persons With HIV

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)Enrollment186HIVMajor Depressive DisorderMild Neurocognitive Disorder
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

A phase II, randomized, open-label, two-arm clinical trial evaluating the safety and efficacy of pramipexole extended release (ER) versus escitalopram for the treatment of major depressive disorder (MDD) and comorbid MDD with mild neurocognitive disorder (MND) in persons with HIV (PWH). Participants will be assessed comprehensively and briefly at intercurrent visits to monitor for toxicity, response to therapy, and to assess for dose changes. An optional sub-study to evaluate treatment impact on the cerebrospinal fluid (CSF) profile will be conducted in a subset of 36 participants.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

41 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Botswana
  • Gaborone Crs

    Gaborone, Botswana

Brazil
  • Instituto de Pesquisas Em Aids Do Rio Grande Do Sul - Ipargs Crs

    Porto Alegre, Rio Grande do Sul, Brazil

  • Instituto de Pesquisa Clinica Evandro Chagas (ipec) Crs

    Rio de Janeiro, Brazil

India
  • Byramjee Jeejeebhoy Medical College (bjmc) Crs

    Pune, Maharashtra, India

Kenya
  • Moi University Clinical Research Center (mucrc) Crs

    Eldoret, Rift Valley, Kenya

  • Kenya Medical Research Institute/walter Reed Project Clinical Research Center (kemri/wrp) Crs

    Kericho, Rift Valley, Kenya

Malawi
  • Blantyre Crs

    Blantyre, Malawi

Mexico
  • Nutrición-Mexico Crs

    Mexico City, Tlalpan, Mexico

Peru
  • Barranco Crs

    Lima, Peru

Philippines
  • de la Salle Medical and Health Sciences Institute - Angelo King Medical Research Center (dlsmhsi-Akmrc)

    Dasmariñas, Cavite, Philippines

South Africa
  • Durban International Crs

    Mount Edgecombe, South Africa

Thailand
  • Thai Red Cross Aids Research Centre (trc-Arc) Crs

    Pathum Wan, Bangkok, Thailand

  • Chiang Mai University Hiv Treatment (cmu Hiv Treatment) Crs

    Chiang Mai, Thailand

Uganda
  • Joint Clinical Research Centre (jcrc)/kampala Crs

    Kampala, Uganda

United States
  • Alabama Crs

    Birmingham, Alabama, United States

  • University of California, Los Angeles Care Center Crs

    Los Angeles, California, United States

  • Ucsd Antiviral Research Center Crs

    San Diego, California, United States

  • University of California, San Francisco Hiv/aids Crs

    San Francisco, California, United States

  • Harbor University of California, Los Angeles Center Crs

    Torrance, California, United States

  • University of Colorado Hospital Crs

    Aurora, Colorado, United States

  • Whitman-Walker Institute, Inc. Crs

    Washington D.C., District of Columbia, United States

  • the Ponce de Leon Center Crs

    Atlanta, Georgia, United States

  • Northwestern University Crs

    Chicago, Illinois, United States

  • Massachusetts General Hospital Crs (mgh Crs)

    Boston, Massachusetts, United States

  • Washington University Therapeutics (wt) Crs

    St Louis, Missouri, United States

  • New Jersey Medical School Clinical Research Center Crs (site Id 31786)

    Newark, New Jersey, United States

  • Columbia Physicians & Surgeons (p&s) Crs

    New York, New York, United States

  • Weill Cornell Chelsea Crs

    New York, New York, United States

  • Weill Cornell Uptown Crs

    New York, New York, United States

  • University of Rochester Adult Hiv Therapeutic Strategies Network Crs

    Rochester, New York, United States

  • Chapel Hill Crs

    Chapel Hill, North Carolina, United States

  • Greensboro Crs

    Greensboro, North Carolina, United States

  • Cincinnati Crs

    Cincinnati, Ohio, United States

  • Case Crs

    Cleveland, Ohio, United States

  • Ohio State University Crs

    Columbus, Ohio, United States

  • Penn Therapeutics Crs

    Philadelphia, Pennsylvania, United States

  • University of Pittsburgh Crs

    Pittsburgh, Pennsylvania, United States

  • Vanderbilt Therapeutics (vt) Crs

    Nashville, Tennessee, United States

  • Houston Advancing Research Team Crs

    Houston, Texas, United States

Vietnam
  • Hanoi Medical University (hmu)

    Hanoi, Vietnam

1 more site on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Escitalopram →Pramipexole ER
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
17 May 2026
Primary completion
2 Dec 2026
Completion
2 Dec 2026
Last update posted
14 Jul 2026
Registered enrollment
186
Registry id
NCT06705478
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.